Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes

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- To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls

Secondary Objectives:

- To evaluate in both paediatric and adult populations:

the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single subcutaneous ascending doses

the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast

safety and tolerability.

Condition or disease

Intervention/treatment

Phase

Type 2 Diabetes Mellitus

Drug: Lixisenatide (AVE0010)Drug: Placebo

Phase 1

Detailed Description:

The duration of the study for each patient is planned between 4 and 7 weeks including a screening period (25 to 30 days), 3 treatment periods 1-7 days apart, each period lasting only one day (Day 1) and an end-of-study visit between 1 to 7 days after the last dose administration.

GLU-AUC 0:30-4:30h: area under the plasma glucose concentration time profile from time of the standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later subtracting the pre-meal value [ Time Frame: D1 at each period up to 4h30 after study drug injection (8 timepoints) ]

Pharmacokinetic parameter (Cmax) [ Time Frame: calculated over the period of timepoints at D1 of each study period ]

Pharmacokinetic parameter (Tmax) [ Time Frame: calculated over the period of timepoints at D1 of each study period ]

Pharmacokinetic parameter (AUC last) [ Time Frame: estimated over the period of timepoints at D1 of each study period ]

Pharmacokinetic parameter (AUC) [ Time Frame: extrapolated based on the period of timepoints at D1 of each study period ]

Area under the concentration time profile from time of standardized breakfast start (30 min after IMP injection) until 4 hours later for insulin, C-peptide and glucagon [ Time Frame: D1 at each period up to 4h30 after study drug injection (7 timepoints) ]

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Ages Eligible for Study:

10 Years to 65 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria :

Male or female patients with type 2 diabetes mellitus, as defined by WHO (fasting plasma glucose ≥ 7 mmol/L (126mg/dL) or 2 hours postprandial plasma glucose ≥ 11.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year (adults) and at least 3 months for paediatric population at the time of screening visit, with or without metformin (stable dose ± 10 % for at least 4 weeks prior to randomization)

HbA1c ≥ 7% and ≤ 10% at screening

Age eligibility for paediatric population: ≥ 10 years and <18 years with at least 3 patients below 15 years and no more than 3 patients aged between 16 and 18 years; Age eligibility for adults: ≥ 18 and ≤ 65 years

Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., alpha glucosidase inhibitor, exenatide, DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening

Allergic reaction to any GLP-1 agonist in the past (e.g. exenatide, liraglutide) or to metacresol